The President’s Council of Advisors on Science and ...



ID #Stage 2 Final RuleStage 3 RecommendationsProposed for Future StageHITPC Questions / CommentsImprove population and public healthSGRP401AEP/EH Objective: Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practiceEP/EH Measure: Successful ongoing submission of electronic immunization data from Certified EHR Technology to an immunization registry or immunization information system for the entire EHR reporting periodEP/ EH Objective: Capability to receive a patient’s immunization history supplied by an immunization registry or immunization information system, and to enable healthcare professionals to use structured historical immunization events in the clinical workflow, except where prohibited, and in accordance with applicable law and practice.Measure: Documentation of timely and successful electronic receipt by the Certified EHR Technology of vaccine history (including null results) from an immunization registry or immunization information system for 30% of patients who received immunizations from the EP/EH during the entire EHR reporting period.Exclusion: EPs and EHs that administer no immunizations or jurisdictions where immunization registries/immunization information systems cannot provide electronic immunization histories.Certification criteria: EHR is able to receive and present a standard set of structured, externally-generated, immunization history and capture the act and date of review within the EP/EH practice.EP/EH Objective: Add submission of vaccine contraindication(s) and reason(s) for substance refusal to the current objective of successful ongoing immunization data submission to registry or immunization information systems.PUBLIC COMMENTS:Concerns This objective requires CEHRT and health department readiness Readiness/maturity of bidirectional information exchange capabilities, as well as data and interoperability standardsExcessive burden for providers with patients from different states with different immunization requirements.ThresholdAt the provider level or organization level? Mixed support for the 30% threshold, some suggest we make this a measure by attestation rather than a threshold, since it is new; others suggested a higher threshold HITSC COMMENTS:At present there is not a vocabulary standard for describing adverse events/contraindications, but the Standards Committee agrees this is an important gap to resolve.SGRP402AEH Objective: Capability to submit electronic reportable laboratory results to public health agencies, except where prohibited, and in accordance with applicable law and practiceMeasure: Successful ongoing submission of electronic reportable laboratory results from Certified EHR Technology to public health agencies for the entire EHR reporting period.EH Objective (unchanged): No change from current requirement for electronic lab reporting which generally is sent from the laboratory information system?PUBLIC COMMENTS:Summary statement: Most commenters agree to keeping this measure unchanged although the standards and Implementation Guide for this measure should be updated to reflect current Public Health requirements.Key PointsMost agree to keeping as coreAn updated Implementation Guide needs to be developed with strict enforcement of LOINC and SNOMEDSome feel that Laboratory functions should not be part of Meaningful Use and that this requirement should be removedMany commenters also mention that capacity at the state level is still an issue and that states require additional resources to ensure that they can receive this data.SGRP402BNew New EP Objective: Capability to use externally accessed or received knowledge (e.g. reporting criteria) to determine when a case report should be reported and then submit the initial report to a public health agency, except where prohibited, and in accordance with applicable law and practice.Measure: Attestation of submission of standardized initial case reports to public health agencies on 10% of all reportable disease or conditions during the entire EHR reporting period as authorized, and in accordance with applicable state/local law and practice.Certification criteria: The EHR uses external data to prompt the end-user when criteria are met for case reporting. The date and time of prompt is available for audit. Standardized (e.g., consolidated CDA) case reports are submitted to the state/local jurisdiction and the data/time of submission is available for audit. Could similar standards be used as those for clinical trials (SGRP209)?PUBLIC COMMENTS:Summary statement: Majority of commenters support the inclusion of this objective in either Stage 3 core set or the future stages of Meaningful Use, with some concerns expressed about- the readiness of public health agencies to receive this data electronically, the maturity and availability of content (say Consolidated CDA) and vocabulary standards (LOINC mapping to lab results) for receiving knowledge or accessing this knowledge and why eligible hospitals (EHs) are not included for this objective?Key PointsThis recommendation isn’t specific to a specific reportable disease, CDC should work closely with the Council of State and Territorial Epidemiologists to define the cases which would be reported electronically. Commenters have provided pointers to pilots conducted earlier by CDC (in New York State, San Diego County and Delaware) and Public Health Data Standards Consortium (PHDSC).References have been provided to current work in progress, the Reportable Conditions Knowledge Management System (RCKMS) through collaboration between CDC and CSTE, which can serve as a source of information on reporting criteria used by an EHR system. The Standards & Interoperability Public Health Reporting Initiative (PHRI) has developed draft implementation guide for public health reporting based on Consolidated CDA (cCDA), which is likely to be pilot tested in Spring 2013, and will provide the necessary standards for electronic case reporting in 2016 for Stage 3 MU. Some commenters have recommended that case reporting from EHRs to meet the Stage 3 Meaningful Use objective need to include, only the basic level of information traditionally received via paper forms such as the “public health card.” Including only this core information for initial reports would allow a generalized approach to case reporting functionality in EHR systems that could apply to any reportable disease or condition.Certification criteria for public health case reporting should allow for different methods for EHR systems to utilize “externally accessed or received knowledge.” Depending on clinician needs and preferences, these methods might range from fully automated detection of reportable diseases and submission of reports to use of clinical decision support that prompts providers to manually submit reports.Clarity requested on whether this would be 10% of all infectious disease cases that should be reported or whether this would include 100% of reporting for 10% of all diseases. Additionally, it is unclear to majority of commenters how this would be evaluated. HITSC COMMENTS:See SGRP 105,106SGRP403EP MENU Objective: Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practiceEH Objective: Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practice EP/EH Measure: Successful ongoing submission of electronic syndromic surveillance data from Certified EHR Technology to a public health agency for the entire EHR reporting period No change from current requirements.?PUBLIC COMMENTS:Summary statement: Most commenters agree that this measure should remain unchanged. However, several commenters point out that the standards are still not mature, especially for EPs; many states are not ready and that states need additional funding to implement this measure. Many commenters want better standards and more efforts aimed at state readiness. Also the providers that the measure pertains to need to be clarified including the addition of inpatient hospital reporting.SGRP404EP only MENU Objective: Capability to identify and report cancer cases to a public health central cancer registry, except where prohibited, and in accordance with applicable law and practice.EP only MENU Measure: Successful ongoing submission of cancer case information from CEHRT to a public health central cancer registry for the entire EHR reporting periodEH/EP Objective: Capability to electronically submit standardized (i.e., data elements and transport mechanisms), commonly formatted reports to two registries (e.g., local/state health departments, professional or other aggregating resources) from the Certified EHR Technology, except where prohibited, and in accordance with applicable law and practice. This objective is in addition to and does not replace prior requirements for submission to an immunization registry. 1) Mandated jurisdictional registries (e.g., cancer, children with special needs, and/or early hearing detection and intervention) 2) Additional community-based (e.g., ACO, public health agency, or specialty community) registries (e.g., hypertension, diabetes, body mass index, devices, health-care associated infections, and/or other diagnoses/conditions).Measure: Documentation of ongoing successful electronic transmission of standardized reports from the Certified EHR Technology to two registries (i.e., ?jurisdictional, professional or another aggregating resource).? Attestation of submission for at least 10% of all patients who meet registry inclusion criteria during the entire EHR reporting period as authorized, and in accordance with applicable State law and practice.Certification criteria: EHR is able to build and then send a standardized report (e.g., standard message format) to an external mandated registry, maintain an audit of those reports, and track total number of reports sent.Exclusion: where local or state health departments have no mandated registries or are incapable of receiving these standardized reports ?PUBLIC COMMENTS:Commenters concerned about the expansion of the scope beyond cancer registries Key PointsMany commenters did not want the scope expanded to include other registries Commenters concerned about the impact on the cancer registry from the expansion to include EH, as many already have established reporting mechanisms in placeUniform reporting needs to be adopted prior to including other registries ? Keep in menu set if including other registries, but recommend core if limiting to cancer registryRecommend exclusions (e.g. exclude those who have existing reporting mechanisms from hospital cancer registries to public health central cancer registries)? Cancer registry concerns Concerns that by “lumping” cancer reporting with other registry reporting, it could diminish the cancer cases that are reported to public healthKeeping a separate item for cancer is preferable – this allows cancer registry to be moved to core while other registries are added as menu The cancer registry community may not be prepared to change the current reporting systems from hospital, which is quite extensiveCancer reporting is well established and has a set of national standards, while other registries are much less defined. Standardize reporting requirement concerns Suggestions for a national effort to standardize the formats of state registries In practice this is proving to be difficult because of inconsistent standards. We encourage maintaining tight standards for sending and receiving systems in Stage 3 The certification criteria leave a lot of room for the vendor to generate the files in various formats yet the actual state or federal bodies (mostly state) require very specific formats that are not met by the vendors since the vendors most likely will not develop formats for all states This objective is premature since many receiving registries are not yet ready for the data stream Need to work on capability to have registry information returned to consumer and provider (bi-directional feedback) HITSC COMMENTS:Standards to submit data from an EHR to a registry are not yet mature. Need to clarify what a "mandated" registry meansSGRP408New New EH/EP Objective: Capability to electronically send adverse event reports (e.g., vaccines, devices, EHR, drugs or biologics) to the Federal Drug Administration (FDA) and/or Centers for Disease Control and Prevention (CDC) from the Certified EHR, except where prohibited, and in accordance with applicable law and practice.Measure: Attestation of successful electronic transmission of standardized adverse event reports to the FDA/CDC from the Certified EHR Technology. Total numeric count (null is acceptable) of adverse event reports from the EH/EP submitted electronically during the entire EHR reporting period as authorized, and in accordance with applicable State law and practice.Certification criteria: EHR is able to build and send a standardized adverse event report message to FDA/CDC and maintain an audit of those reports sent to track number of reports sent (Common Format).PUBLIC COMMENTS:The majority of comments were supportive of requiring the capability to electronically send adverse event reports (e.g., vaccines, devices, EHR, drugs or biologics) to the Federal Drug Administration (FDA) and/or Centers for Disease Control and Prevention (CDC) from the Certified EHR. The main benefits of such requirement were identified as promotion of increased number of reports received and increase quality of the content. Some noted this as a crucial function for patient safety and public health and argued that it not be delayed until future- Stage 4. Several comments noted the presence of this functionality in several current EHRs and that it was a positive feature in these systems. Comments not supportive of this item noted this function was not known to be present in any current systems, concerns that the FDA and CDC were not ready or capable of receiving these reports, and concerns that reporting should not be a function of electronic records as this was often currently done using an outside system or module and that completion of adverse events reports in the electronic health record would be discoverable and not secure.Several theme areas where clarification is needed were noted. Many comments indicated a need to clearly define what is meant by an adverse event and what needs to be reported. Concern expressed that it may lead to more reporting requirements and concern that these will not align with current reporting requirements. Clarification is needed to indicate that the electronic record is a source for the information and not to complete the function of reporting. HITSC COMMENTS:At present adverse event reporting systems, and not EHRs support this functionality. Unclear if EHR workflow would support such a function.Certification Criteria ONLYSGRP401BNew EP/EH Objective: Capability to receive, generate or access appropriate age-, gender- and immunization history-based recommendations (including immunization events from immunization registries or immunization information systems) as applicable by local or state policy.Measure: Implement an immunization recommendation system that: 1) establishes baseline recommendations (e.g., Advisory Committee on Immunization Practices), and 2) allows for local/state variations. For 20% of patients receiving an immunization, the EP/EH practice receives the recommendation before giving an immunization.Exclusion: EPs and EHs that administer no immunizations. Certification criteria: EHR uses a standard (e.g., national, state and/or local) rule set, plus patient age, gender, and prior immunization history to recommend administration of immunizations; capture the act and date/time of recommendation review.?PUBLIC COMMENTS:Commenters were generally supportive of the objective, but expressed concern about the feasibility of achieving it (and meeting the measure target threshold) in the Stage 3 timeframe. Many were concerned with the lack of available standards, the readiness of technology, etc. One major objection shared by multiple commenters was that the measure would incentivize the wrong behavior – reviewing history might not necessarily lead to improvements in immunization rates.HITSC COMMENTS:At present there is no standard to represent immunization rulesSGRP405EP only MENU Objective: Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice.EP only MENU Measure: Successful ongoing submission of specific case information from Certified EHR Technology to a specialized registry for the entire EHR reporting periodEP Objective: Capability to electronically submit standardized reports to an additional registry beyond any prior meaningful use requirements (e.g., immunizations, cancer, early hearing detection and intervention, and/or children with special needs). Registry examples include hypertension, diabetes, body mass index, devices, and/or other diagnoses/conditions) from the Certified EHR to a jurisdictional, professional or other aggregating resources (e.g., HIE, ACO), except where prohibited, and in accordance with applicable law and practice.Measure: Documentation of successful ongoing electronic transmission of standardized (e.g., consolidated CDA) reports from the Certified EHR Technology to a jurisdictional, professional or other aggregating resource. Attestation of submission for at least 10% of all patients who meet registry inclusion criteria during the entire EHR reporting period as authorized, and in accordance with applicable state/local law and practice.Certification criteria: EHR is able to build and send a standardized message report format to an external registry, maintain an audit of those reports, and track total number of reports sent. PUBLIC COMMENTS:Support for changes, but more specificity needed.HITSC COMMENTS:Need to clarify what a "non-mandated" registry means. It may be very difficult to certify products to support this criteria since "non-mandated" registries are likely to be niche/non-standard.SGRP407New EH Objective: Capability to electronically send standardized Healthcare Associated Infection (HAI) reports to the National Healthcare Safety Network (NHSN) using a common format from the Certified EHR, except where prohibited, and in accordance with applicable law and practice. Measure: Documentation of successful electronic transmission of standardized healthcare acquired infection reports to the NHSN from the Certified EHR Technology. Total numeric count of HAI in the hospital and attestation of Certified EHR electronic submission of at least 10% of all reports during the entire EHR reporting period as authorized, and in accordance with applicable State law and practice.Certification criteria: EHR is able to send a standard HAI message to NHSN, maintain an audit and track total number of reports sent.?PUBLIC COMMENTS:Comments for SGRP 407 - Capability to electronically send standardized Healthcare Associated Infection (HAI) reports to the National Healthcare Safety Network (NHSN) using a common format from the Certified EHR, except where prohibited, and in accordance with applicable law and practice- was split between favorable and unsupportive. Comments in favor of this sited that this function was already in place and operating within some electronic health records. They also noted that it was aligned with the Federal goals of decreasing HAIs. Negative comments noted the need for more Federal funding and support of implementation of this function. They noted that determining an HAI by NHSN criteria was not a simple function for an electronic health record and that it usually involved manual review of data and chart audit. Multiple comments also felt it was premature as the pilot of electronic transmission to NHSN is currently only conceptualized, and has not yet been competed or produced results.HITSC COMMENTS:Hospital Acquired Infection content standards are low maturity ................
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